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临床试验/NCT05174260
NCT05174260已完成不适用

Predictability of Hemodynamic Instability With Increase in Perfusion Index (PI) and Pleth Variability Index (PVI) Values After Spinal Block in Elective Cesarean Sections

Adiyaman University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
perfusion index (PI)

研究概览

简要总结

In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.

详细描述

In recent years, the trend towards noninvasive monitoring methods has increased instead of invasive monitoring methods. Plet Variability Index (PVI), perfusion index (PI) are non-invasive, easily applicable and easily interpretable new monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted, especially with Plet Variability Index (PVI) monitoring. Hypotension is the most common complication of spinal anesthesia. If no precautions are taken, it is seen in 80-90% of cases. associated with a decrease in peripheral vascular resistance. Recent studies have shown that cardiac output does not decrease, but slightly increases or does not change, and venous return does not change with spinal anesthesia. Aortocaval compression may exacerbate hypotension due to neuraxial anesthesia. The PI is obtained by calculating the ratio of pulsatile blood flow to nonpulsatile blood flow in peripheral tissues by pulse oximetry. This ratio reflects changes in peripheral vascular resistance. For example, a low PI indicates peripheral vasoconstriction. PVI represents changes in PI that occur during one or more complete respiratory cycles. Provides evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In some studies, it is stated that PI and PVI values obtained from pulse oximetry are predictive for SA-induced hypotension in cesarean deliveries; There are also studies in the literature showing the opposite. In this study, the researchers aimed to test the hypothesis that hypotension can be predicted by using PVI representing cardiac preload and PI representing vascular tone in pregnant women after spinal anesthesia and to examine the superiority of these values.

OBJECTIVE: Today, spinal anesthesia (SA); Since it is less risky for maternal and new born health compared to general anesthesia, it is a more preferred method in elective cesareansection operations. Hypotension due to spinal anesthesia, which is the most common side effect of spinal anesthesia, is frequently seen in patients. Due to the negative consequences of hypotension on the mother and newborn; It is important to take the necessary precautions against this hemodynamic deterioration. Perfusion index (PI) and pleth variability index (PVI) are parameters that can be measured noninvasively by pulseoximetry. In our study; By examining the lower extremity PI and PVI values in patients who will undergo elective cesareansection with SA; We investigated the usability and superiority of these values over each other in predicting hemodynamic deterioration.

METHODS: This research; It was conducted as a prospective observational study and 113 pregnant women aged 18-40 years who were ASA1-2 who were going to undergo lower segment cesarean section were included in our study. Demographic data of the patients (age, gender, weight, height, BMI) and routine hemogram values (hemoglobin, hematocrit, platelet, wbc) taken for preoperative evaluation were recorded. After the patients were placed on the operating table, PI and PVI values in the supine and sitting positions, PI and PVI values at the 1st, 2nd, 3rd, and 4th minutes after spinal anesthesia was applied to the patient, and finally, the postpartum PI, PVI values were recorded. In addition, in order to follow up the hemodynamic changes in all patients in thes tudy, Standard monitoring including electrocardiography, non-invasive blood pressure measurements and pulse measurement was performed, and changes in systolic pressure, diastolic pressure and heart rate were recorded before and after spinal anesthesia.

In our study, in which we examined PI and PVI values in predicting hypotension due to spinal anesthesia in elective C/S operations, we have reached the following results.

Unlike other studies in the literature; In our study, in which we followed the PI and PVI values in the lower extremities together and examined the diagnostic superiority of these values to each other and the relationship between the hemogram and hematocrit values of the patients, we did not find a statistically significant difference in the increase in the lower extremity basal PI and PVI values in the patient groups with and without hypotension. We interpreted this situation as lower extremity basal PI and PVI values were not effective in predicting hypotension due to spinal anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who will undergo elective cesarean section
  • Patients with ASA 1-2
  • Patients aged 18-40 years

排除标准

  • Emergency cases
  • <18 or > 40 years old
  • Gestational age <36 weeks
  • Cardiovascular disease
  • Patients with ASA 3-4
  • Those with peripheral vascular disease
  • Patients for whom spinal anesthesia is contraindicated
  • Refusal to participate

结局指标

主要结局

perfusion index (PI)

时间窗: perioperative

Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.

pleth variability index (PVI)

时间窗: perioperative

Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PVI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.

BMİ-weight,

时间窗: preoperratif value

There was no difference in BMI and weight values between patients who developed and did not develop hypotension after spinal anesthesia

hemoglobin

时间窗: preoperatif value

Hemoglobin (p=0.014) and hematocrit (p=0.012) values weres ignificantly lower in pregnant women who developed hypotension

APGAR

时间窗: the 1st minute APGAR-the 5th minute APGAR

The 1st minute APGAR (p=0.005= and 5th minute APGAR (p=0.014) scores were significantly lower in the babies of pregnant women who developed hypotension.

次要结局

  • diastolic blood pressure(perioperative)
  • systolic blood pressure(perioperative)
  • pulse(perioperative)

研究者

发起方
Adiyaman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ESMA KAPLAN ÇALIŞKAN

assistant doctor

Adiyaman University

研究点 (1)

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